(a) infant formula and follow-on formula; (b) processed cereal-based food and baby food; (c) food for special medical purposes; (d) total diet replacement for weight control.
Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 Text with EEA relevance
Modified by
- Commission Delegated Regulation (EU) 2017/1091of 10 April 2017amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the list of substances that may be added to processed cereal-based food and baby food and to food for special medical purposes(Text with EEA relevance), 32017R1091, June 21, 2017
- Commission Delegated Regulation (EU) 2021/571of 20 January 2021amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the list of substances that may be added to infant and follow-on formula, baby food and processed cereal-based food(Text with EEA relevance), 32021R0571, April 8, 2021
(a) the definitions of "food", "food business operator", "retail" and "placing on the market" set out respectively in Article 2 and points (3), (7) and (8) of Article 3 of Regulation (EC) No 178/2002; (b) the definitions of "prepacked food", "labelling" and "engineered nanomaterial" set out respectively in points (e), (j) and (t) of Article 2(2) of Regulation (EU) No 1169/2011; (c) the definitions of "nutrition claim" and "health claim" set out respectively in points (4) and (5) of Article 2(2) of Regulation (EC) No 1924/2006.
(a) "infant" means a child under the age of 12 months; (b) "young child" means a child aged between one and three years; (c) "infant formula" means food intended for use by infants during the first months of life and satisfying by itself the nutritional requirements of such infants until the introduction of appropriate complementary feeding; (d) "follow-on formula" means food intended for use by infants when appropriate complementary feeding is introduced and which constitutes the principal liquid element in a progressively diversified diet of such infants; (e) "processed cereal-based food" means food: (i) intended to fulfil the particular requirements of infants in good health while they are being weaned, and of young children in good health as a supplement to their diet and/or for their progressive adaptation, to ordinary food; and (ii) pertaining to one of the following categories: simple cereals which are or have to be reconstituted with milk or other appropriate nutritious liquids, cereals with an added high protein food which are or have to be reconstituted with water or other protein-free liquid, pastas which are to be used after cooking in boiling water or other appropriate liquids, rusks and biscuits which are to be used either directly or, after pulverisation, with the addition of water, milk or other suitable liquids;
(f) "baby food" means food intended to fulfil the particular requirements of infants in good health while they are being weaned, and of young children in good health as a supplement to their diet and/or for their progressive adaptation to ordinary food, excluding: (i) processed cereal-based food; and (ii) milk-based drinks and similar products intended for young children;
(g) "food for special medical purposes" means food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone; (h) "total diet replacement for weight control" means food specially formulated for use in energy restricted diets for weight reduction which, when used as instructed by the food business operator, replaces the whole daily diet.
(a) whether a given food falls within the scope of this Regulation; (b) to which specific category of food referred to in Article 1(1) a given food belongs.
(a) the specific compositional requirements applicable to food referred to in Article 1(1), with the exception of requirements as set out in the Annex; (b) the specific requirements on the use of pesticides in products intended for the production of food referred to in Article 1(1) and on pesticide residues in such food. The specific requirements for the categories of food referred to in points (a) and (b) of Article 1(1) and food for special medical purposes developed to satisfy the nutritional requirements of infants and young children shall be updated regularly and include, inter alia, provisions to restrict the use of pesticides as much as possible; (c) the specific requirements on labelling, presentation and advertising of food referred to in Article 1(1), including the authorisation of nutrition and health claims in relation thereto; (d) the notification requirements for the placing on the market of food referred to in Article 1(1), in order to facilitate the efficient official monitoring of such food, and on the basis of which food business operators shall notify the competent authorities of Member States where that food is being marketed; (e) the requirements concerning promotional and commercial practices relating to infant formula; (f) the requirements concerning information to be provided in relation to infant and young child feeding in order to ensure adequate information on appropriate feeding practices; (g) the specific requirements for food for special medical purposes developed to satisfy the nutritional requirements of infants, including compositional requirements and requirements on the use of pesticides in products intended for the production of such food, pesticide residues, labelling, presentation, advertising, and promotional and commercial practices, as appropriate.
(a) vitamins; (b) minerals; (c) amino acids; (d) carnitine and taurine; (e) nucleotides; (f) choline and inositol.
(a) the category of food referred to in Article 1(1) to which substances belonging to the categories of substances listed in paragraph 1 of this Article may be added; (b) the name, the description of the substance and, where appropriate, the specification of its form; (c) where appropriate, the conditions of use of the substance; (d) where appropriate, the purity criteria applicable to the substance.
(a) the removal of a category of substances; (b) the addition of a category of substances that have a nutritional or physiological effect.
(a) the addition of a substance to the Union list; (b) the removal of a substance from the Union list; (c) the addition, removal or amendment of the elements referred to in Article 15(3).
Articles 11, 16, 18 and 19 which shall apply from 19 July 2013 .Article 15 and the Annex to this Regulation which shall apply from the date of application of the delegated acts referred to in Article 11(1).
Substance | Category of food | |||||
---|---|---|---|---|---|---|
Infant formula and follow on formula | Processed cereal-based food and baby food | Food for special medical purposes | Total diet replacement for weight control | |||
Vitamins | ||||||
Vitamin A | ||||||
retinol | X | X | X | X | ||
retinyl acetate | X | X | X | X | ||
retinyl palmitate | X | X | X | X | ||
beta-carotene | X | X | X | |||
Vitamin D | ||||||
ergocalciferol | X | X | X | X | ||
cholecalciferol | X | X | X | X | ||
Vitamin E | ||||||
D-alpha tocopherol | X | X | X | X | ||
DL-alpha tocopherol | X | X | X | X | ||
D-alpha tocopheryl acetate | X | X | X | X | ||
DL-alpha tocopheryl acetate | X | X | X | X | ||
D-alpha-tocopheryl acid succinate | X | X | ||||
D-alpha-tocopheryl polyethylene glycol-1000 succinate (TPGS) | X | |||||
Vitamin K | ||||||
phylloquinone (phytomenadione) | X | X | X | X | ||
Menaquinone | X | X | ||||
Vitamin C | ||||||
L-ascorbic acid | X | X | X | X | ||
sodium-L-ascorbate | X | X | X | X | ||
calcium-L-ascorbate | X | X | X | X | ||
potassium-L-ascorbate | X | X | X | X | ||
L-ascorbyl 6-palmitate | X | X | X | X | ||
Thiamin | ||||||
thiamin hydrochloride | X | X | X | X | ||
thiamin mononitrate | X | X | X | X | ||
Riboflavin | ||||||
riboflavin | X | X | X | X | ||
riboflavin 5’-phosphate, sodium | X | X | X | X | ||
Niacin | ||||||
nicotinic acid | X | X | X | X | ||
nicotinamide | X | X | X | X | ||
Vitamin B | ||||||
pyridoxine hydrochloride | X | X | X | X | ||
pyridoxine 5’-phosphate | X | X | X | X | ||
pyridoxine dipalmitate | X | X | X | |||
Folate | ||||||
folic acid (pteroylmonoglutamic acid) | X | X | X | X | ||
calcium-L-methylfolate | X | X | X | X | ||
Vitamin B | ||||||
cyanocobalamin | X | X | X | X | ||
hydroxocobalamin | X | X | X | X | ||
Biotin | ||||||
D-biotin | X | X | X | X | ||
Pantothenic Acid | ||||||
D-pantothenate, calcium | X | X | X | X | ||
D-pantothenate, sodium | X | X | X | X | ||
dexpanthenol | X | X | X | X | ||
Minerals | ||||||
Potassium | ||||||
potassium bicarbonate | X | X | X | |||
potassium carbonate | X | X | X | |||
potassium chloride | X | X | X | X | ||
potassium citrate | X | X | X | X | ||
potassium gluconate | X | X | X | X | ||
potassium glycerophosphate | X | X | X | |||
potassium lactate | X | X | X | X | ||
potassium hydroxide | X | X | X | |||
potassium salts of orthophosphoric acid | X | X | X | |||
magnesium potassium citrate | X | X | ||||
Calcium | ||||||
calcium carbonate | X | X | X | X | ||
calcium chloride | X | X | X | X | ||
calcium salts of citric acid | X | X | X | X | ||
calcium gluconate | X | X | X | X | ||
calcium glycerophosphate | X | X | X | X | ||
calcium lactate | X | X | X | X | ||
calcium salts of orthophosphoric acid | X | X | X | X | ||
calcium hydroxide | X | X | X | X | ||
calcium oxide | X | X | X | |||
calcium sulphate | X | X | ||||
calcium bisglycinate | X | X | ||||
calcium citrate malate | X | X | ||||
calcium malate | X | X | ||||
calcium L-pidolate | X | X | ||||
calcium phosphoryl oligosaccharides | X | |||||
Magnesium | ||||||
magnesium acetate | X | X | ||||
magnesium carbonate | X | X | X | X | ||
magnesium chloride | X | X | X | X | ||
magnesium salts of citric acid | X | X | X | X | ||
magnesium gluconate | X | X | X | X | ||
magnesium glycerophosphate | X | X | X | |||
magnesium salts of orthophosphoric acid | X | X | X | X | ||
magnesium lactate | X | X | X | |||
magnesium hydroxide | X | X | X | X | ||
magnesium oxide | X | X | X | X | ||
magnesium sulphate | X | X | X | X | ||
magnesium L-aspartate | X | |||||
magnesium bisglycinate | X | X | ||||
magnesium L-pidolate | X | X | ||||
magnesium potassium citrate | X | X | ||||
Iron | ||||||
ferrous carbonate | X | X | X | |||
ferrous citrate | X | X | X | X | ||
ferric ammonium citrate | X | X | X | X | ||
ferrous gluconate | X | X | X | X | ||
ferrous fumarate | X | X | X | X | ||
ferric sodium diphosphate | X | X | X | |||
ferrous lactate | X | X | X | X | ||
ferrous sulphate | X | X | X | X | ||
ferrous ammonium phosphate | X | X | ||||
ferric sodium EDTA | X | X | ||||
ferric diphosphate (ferric pyrophosphate) | X | X | X | X | ||
ferric saccharate | X | X | X | |||
elemental iron (carbonyl + electrolytic + hydrogen reduced) | X | X | X | |||
ferrous bisglycinate | X | X | X | X | ||
ferrous L-pidolate | X | X | ||||
Zinc | ||||||
zinc acetate | X | X | X | X | ||
zinc chloride | X | X | X | X | ||
zinc citrate | X | X | X | X | ||
zinc gluconate | X | X | X | X | ||
zinc lactate | X | X | X | X | ||
zinc oxide | X | X | X | X | ||
zinc carbonate | X | X | ||||
zinc sulphate | X | X | X | X | ||
zinc bisglycinate | X | X | ||||
Copper | ||||||
cupric carbonate | X | X | X | X | ||
cupric citrate | X | X | X | X | ||
cupric gluconate | X | X | X | X | ||
cupric sulphate | X | X | X | X | ||
copper lysine complex | X | X | X | X | ||
Manganese | ||||||
manganese carbonate | X | X | X | X | ||
manganese chloride | X | X | X | X | ||
manganese citrate | X | X | X | X | ||
manganese gluconate | X | X | X | X | ||
manganese glycerophosphate | X | X | X | |||
manganese sulphate | X | X | X | X | ||
Fluoride | ||||||
potassium fluoride | X | X | ||||
sodium fluoride | X | X | ||||
Selenium | ||||||
sodium selenate | X | X | X | |||
sodium hydrogen selenite | X | X | ||||
sodium selenite | X | X | X | |||
selenium enriched yeast | X | X | ||||
Chromium | ||||||
chromium (III) chloride and its hexahydrate | X | X | ||||
chromium (III) sulphate and its hexahydrate | X | X | ||||
chromium picolinate | X | X | ||||
Molybdenum | ||||||
ammonium molybdate | X | X | ||||
sodium molybdate | X | X | ||||
Iodine | ||||||
potassium iodide | X | X | X | X | ||
potassium iodate | X | X | X | X | ||
sodium iodide | X | X | X | X | ||
sodium iodate | X | X | X | |||
Sodium | ||||||
sodium bicarbonate | X | X | X | |||
sodium carbonate | X | X | X | |||
sodium chloride | X | X | X | |||
sodium citrate | X | X | X | |||
sodium gluconate | X | X | X | |||
sodium lactate | X | X | X | |||
sodium hydroxide | X | X | X | |||
sodium salts of orthophosphoric acid | X | X | X | |||
Boron | ||||||
sodium borate | X | X | ||||
boric acid | X | X | ||||
Amino acids | ||||||
L-alanine | — | X | X | |||
L-arginine | X | X | ||||
L-aspartic acid | X | |||||
L-citrulline | X | |||||
L-cysteine | X | X | ||||
Cystine | X | X | ||||
L-histidine | X | X | ||||
L-glutamic acid | X | X | ||||
L-glutamine | X | X | ||||
glycine | X | |||||
L-isoleucine | X | X | ||||
L-leucine | X | X | ||||
L-lysine | X | X | ||||
L-lysine acetate | X | X | ||||
L-methionine | X | X | X | X | ||
L-ornithine | X | X | ||||
L-phenylalanine | X | X | X | X | ||
L-proline | X | |||||
L-threonine | X | X | X | X | ||
L-tryptophan | X | X | X | X | ||
L-tyrosine | X | X | X | X | ||
L-valine | X | X | X | X | ||
L-serine | X | |||||
L-arginine-L-aspartate | X | |||||
L-lysine-L-aspartate | X | |||||
L-lysine-L-glutamate | X | |||||
N-acetyl-L-cysteine | X | |||||
N-acetyl-L-methionine | X (in products intended for persons over 1 year of age) | |||||
Carnitine and taurine | ||||||
L-carnitine | X | X | X | X | ||
L-carnitine hydrochloride | X | X | X | X | ||
taurine | X | X | X | |||
L-carnitine-L-tartrate | X | X | X | |||
Nucleotides | ||||||
adenosine 5’-phosphoric acid (AMP) | X | X | X | |||
sodium salts of AMP | X | X | X | |||
cytidine 5’-monophosphoric acid (CMP) | X | X | X | |||
sodium salts of CMP | X | X | X | |||
guanosine 5’-phosphoric acid (GMP) | X | X | X | |||
sodium salts of GMP | X | X | X | |||
inosine 5’-phosphoric acid (IMP) | X | X | X | |||
sodium salts of IMP | X | X | X | |||
uridine 5’-phosphoric acid (UMP) | X | X | X | |||
sodium salts of UMP | X | X | X | |||
Choline and inositol | ||||||
choline | X | X | X | X | ||
choline chloride | X | X | X | X | ||
choline bitartrate | X | X | X | X | ||
choline citrate | X | X | X | X | ||
inositol | X | X | X | X |